Scott Wolchko - Chief Operating Officer and Chief Financial Officer Christian Weyer - President and Chief Executive Officer Dan Shoemaker - Chief Scientific Officer.
Paul Matteis - Leerink Partners Ren Benjamin - Raymond James Ted Tenthoff - Piper Jaffray Mark Breidenbach - H.C. Wainwright.
Welcome to the Fate Therapeutics' Third Quarter 2015 Financial Results Conference Call. At this time, all participants are in a listen-only mode. This call is being webcast live on the Investors and Media section of Fate's website at fatetherapeutics.com.
This call is the property of Fate Therapeutics and recordings, reproduction or transmission of this call without the expressed written consent of Fate is strictly prohibited. As a reminder, today's call is being recorded. I'd now like to introduce Scott Wolchko, Chief Operating and Financial Officer of Fate Therapeutics..
Thank you. Good afternoon and thanks everyone for joining us for the Fate Therapeutics third quarter 2015 earnings call. Shortly after 4:00 PM Eastern Time today, we issued a press release with our third quarter 2015 financial results, which can be found on the Investors and Media section of our website under press releases.
In addition, our third quarter 2015 10-Q was filed shortly thereafter and can be found on the Investors and Media section of our website under Financial Information.
Before we begin, I'd like to remind everyone that except for statements of historical facts, the statements made by management and responses to questions on this conference call are forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.
These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements.
Please see the forward-looking statement disclaimer on the Company's earnings press release issued after the close of market today, as well as the risk factors in the Company's SEC filings, included in our Form 10-Q for the quarter ended September 30, 2015 that was filed with the SEC today.
Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, as the facts and circumstances underlying these forward-looking statements may change, except as required by law, Fate Therapeutics disclaims any obligations to update these forward-looking statements to reflect future information, events, or circumstances.
Joining me on the call today are Dr. Christian Weyer, President and Chief Executive Officer and Dr. Dan Shoemaker, Chief Scientific Officer. I will now turn the call over to Christian for some opening comments..
Thanks Scott. Good afternoon everyone and thank you for joining our call today. As we announced last month, I have decided to step down from my role as President and CEO, effective November 30. Scott was one of the founders of Fate Therapeutics would be succeeding me as President and CEO effective December 1.
During my tenure as CEO, we have evolved Fate Therapeutics from a private company broadly focused on stem cell biology and the development of therapeutics based on the modulation of different types of stem cells into a public company that has focused most specifically on the modulation of immune cells and the development of programmed cellular immunotherapeutics for cancer and immune disorders.
This evolution has been born out of encouraging clinical data from our ongoing Phase 2 PUMA study of PROHEMA and has also been driven by a significant shift in our strategic direction toward the development of cell-based cancer immunotherapeutics.
Under Scott's leadership and direction the organization has [contrasted] in a tremendous amount in the past several months to execute on their shift in strategy.
We formed a research collaboration in May with Juno Therapeutics to program the therapeutic properties of engineered T-cell immunotherapeutics, partnered with University of Minnesota in July to advance a novel and NK-cell-based therapeutic and focused our proprietary pluripotent cell platform on the development of off-the-shelf engineered T- and NK-cell cancer immunotherapeutics.
We have become a publicly traded Company with a strong balance sheet, and experienced leadership team in a growing highly motivated and focused employee base. With this strong foundation in place, I decided that it was time for me to return to my longstanding area of scientific and drug development expertise.
As many of you know, I've dedicated most of my career to diabetes and metabolic disease research, first within Academia then with the NIH and later with Amylin Pharmaceuticals, and I look forward to returning to my roots in this therapeutic filed.
Scott has been involved in every aspect of Fate's business from the outset, and the Board and I are confident in Scott's dedication to innovation and passion about developing cell-based immunotherapeutics that can profoundly change patient lives and deliver value to our shareholders. We are well positioned for our next stage of development.
There has been a privilege and a pleasure to steer the organization and to act with the Company's stakeholders over the years, and I know that Fate Therapeutics is going to be in very good hands under Scott's leadership. And with that, I'd like to turn the call back over to Scott. Thank you very much..
Thank you, Chris. All of us at Fate Therapeutics appreciate your contributions as CEO and your support involving our strategic direction, and I appreciate the Board's confidence in me to capitalize on the opportunities ahead.
Since the founding of Fate Therapeutics, we have developed scientific leadership in modulating the biological function and directing the fate of cells ex vivo, an approach which we refer to as cell programming. We are dedicated to the development of programs cellular immunotherapeutics for the treatment of cancer and immune disorders.
We seek to develop off-the-shelf cellular immunotherapeutics where program cells can be produced and adoptively transferred to a patient without requiring patient-sourced cells. In pursuit of our therapeutic mission our research and product pipeline is focused on the development of off-the-shelf T- and NK-cell immunotherapeutics.
Therapeutic strategies designed to harness the power of immune cells, have the potential to revolutionize the treatment of cancer and cell-based cancer immunotherapeutics are rapidly emerging as a cornerstone treatment paradigm. We believe patient-sourced T cells represent just the first wave of revolutionary cell-based cancer immunotherapeutics.
To that end, we entered into an exclusive research collaboration in May 2015 with Juno Therapeutics to identify and apply small molecule modulators to enhance the therapeutic properties of engineered T-cells.
The collaboration is off to a very productive start and we are fully engaged in executing against our joint plan and fully committed to ensuring Juno scientific and product development success.
We also believe that off-the-shelf approaches to cell-based cancer immunotherapy which do not require patient-sourced cells offer several compelling advantages and that these off-the-shelf approaches are just now emerging.
One of our top strategic priorities is to build a comprehensive portfolio of off-the-shelf T- and NK-cell cancer immunotherapeutics which we firmly believe will become an integral part of the oncology treatment paradigm. To support this initiative, we partnered with Dr.
Jeff Miller and the University of Minnesota in July 2015 to advancing novel, allogeneic and cell cancer immunotherapeutic, where we aim to leverage the inherent ability of NK-cells to rapidly detect and effectively destroy malignant cells. We believe NK-cells hold unique promise as off-the-shelf therapies.
As part of the innate immune system NK-cells can recognize and kill stressed cells or cells with MHC Class I down regulation without requiring prior antigen exposure or their need for highly specific receptors. And NK-cells do not need to be matched to a patient to achieve this killing effect.
We have also established a leadership position in developing induced pluripotent cells which are capable of long-term self renewal and can be used to generate almost any functional cell. Two of our scientific founders Drs.
Rudolf Jaenisch and Sheng Ding are pioneers in the field and we've fueled a robust platform that allows for a generation and maintenance of pluripotent cells in a consistent scalable and efficient manner. Our pluripotent cell platform is supported by an intellectual property portfolio of over 30 issued patents and 60 pending applications.
We believe that our pluripotent cell platform which combines genetic engineering with rapid and efficient generation of immune cells is disruptive and holds unique potential for the development of off-the-shelf cancer immunotherapies.
Specifically, the platform is designed to enable the generation of highly stable, genetically modified clonal pluripotent cell lines and to utilize these lines for the unlimited production of engineered T-cells and NK-cells without requiring patient-sourced cells.
We believe our therapeutic strategy has the potential to overcome key limitations of patient-sourced approaches such as the requirement to isolate and engineer cells for each individual patient, and our strategy may prove to be the cornerstone of off-the-shelf cancer immunotherapy.
Turning to the rest of our pipeline, our mostly advanced programs are PROHEMA and PROTMUNE, both of which are produced using donor cells.
These product candidates are being developed for patients with hematologic malignancies undergoing allogeneic hematologic cell transplantation, a procedure that is performed with curative intent but is marked by substantial morbidity and mortality.
We believe our cell programming approach may offer a very unique and powerful value proposition to patients undergoing allogeneic HCT.
By programming the donor cell graft prior to its administration life-threatening complications such as acute GvHD and severe infections may be preventing reducing the overall morbidity and mortality of a potentially curative procedure.
We have now achieved 70% of target enrollment in our Phase 2 PUMA study of PROHEMA, which is designed to enroll 60 patients undergoing double umbilical cord transplantation.
The primary endpoint of the clinical trial is based on a cumulative incidence of early neutrophil engraftment, and the trial was power to show with statistical significance that 70% of subjects with neutrophil engraftment in the PROHEMA treatment arm and graft prior to a pre-specified historical control day of engraftment.
We observed that 64% of subjects with neutrophil engraftment in a PROHEMA treatment arm achieved early engraftment in our May 2015 interim data review from our ongoing Phase 2 PUMA study. Neutrophil engraftment remains a key clinical outcome that cannot be adversely affected for patients undergoing transplantation.
Yet we believe based on both preclinical and clinical findings as well as our discussions with KOLs that are more compelling therapeutic and pharmacoeconomic value proposition is the prevention of severe life-threatening infections in patients undergoing HCT.
In our May 2015 interim data review, we observed a 54% reduction in the rate of severe infection related adverse events including severe bacterial fungal and viral infections. An observation which we believe is primarily attributable to our programming of the donor T-cells and the NK-cells that are adaptively transferred to the patient.
Pharmacoeconomic data that we will present at ASH suggests that mean healthcare costs per patient are increased by approximately $170,000 and length of hospital stay is extended by 19 days for patients experiencing one or more infection after HCT compared to those that do not develop any infection.
We are currently preparing an additional interim data cut from our ongoing Phase 2 PUMA study of PROHEMA, and we expect to report additional data on neutrophil engraftment and severe infection related adverse events during the upcoming 2015 ASH Annual Meeting.
PROTMUNE, our product candidate for patients undergoing mobilized peripheral blood transplantation is intended to enhance the immune tolerance and anti-infective activity of the donor cells. We are excited about the potential for PROTMUNE for several reasons.
First, mobilized peripheral blood is the most commonly used graft source for HCT, and its use is increasing.
Secondly, we believe that our self programming approach has the potential to significantly reduce acute GvHD and severe infections, which are life-threatening complications affecting over 50% of mobilized peripheral blood recipients and are leading causes of morbidity and mortality.
We are now finalizing our IND filing for PROTMUNE and we expect to initiate a first in human clinical trial in 2016 to investigate the potential of PROTMUNE to prevent acute GvHD and severe infections in patients undergoing mobilized peripheral blood transplantation.
In the coming weeks, we plan to continue to engage KOLs and to hold the Type C meeting with the FDA to review our ongoing clinical trial observations with PROHEMA.
The purpose of these meetings is to gain expert and regulatory feedback, so that we can prospectively plan and optimize our clinical development strategy in transplantation with the goal of maximizing our likelihood of conducting a successful registrational trial and gaining approval of a product offering the most compelling therapeutic and pharmacoeconomic value proposition.
I will now turn the call over to Dan, who will provide an overview of our near-term clinical milestones including the preclinical data and scientific findings we anticipate presenting at the upcoming American Society of Hematology Conference in December of this year..
Thanks Scott. Our program cellular immunotherapeutics preclinical pipeline is poised to achieve several near-term milestones. At ASH this December, we plan to present two poster sessions highlighting new preclinical findings and the potential therapeutic and pharmacoeconomic value propositions of PROTMUNE.
We believe we are pursuing a fundamentally novel strategy with PROTMUNE in to prevent acute GvHD and severe infections in patients undergoing allogeneic HCT.
Phasing two small molecules to first program that fit therapeutic properties of donor cells, we believe that the immune tolerance and anti-infective activity of the donor cells administered that the patient can be significantly enhanced.
GvHD and severe infections are major complications of allogeneic HCT that significantly impair the quality of life and survival of many recipients. To-date preventive strategies are limited and treatment strategies involve toxic medications that can cause systemic side effects.
New preclinical data to be presented at ASH show that a single administration of program cells results in a statistically significant reduction in GvHD score and improvement in survival as compared to vehicle treated cells and preclinical models.
Importantly, additional preclinical data also demonstrates that the cancer fighting properties of these program cells are preserved. As Scott mentioned, we've focused our preclinical pipeline on the development of off-the-shelf cancer immunotherapeutics.
In July of 2015, we entered into a collaboration with the University of Minnesota and are working with renowned NK-cell biologist Dr.
Jeffrey Miller, Deputy Director of the Masonic Cancer Center and Deputy Director of the Clinical and Translational Science Institute at the University of Minnesota to develop a novel adaptive NK cancer cell immunotherapeutic. Dr.
Miller has demonstrated that are NK-cell product candidate is functioning distinct from conventional NK-cells, having an epigenetic profile similar to that Cytotoxic T-lymphocytes and having for long persistence and enhanced antitumor activity mediated to CD16 signaling in preclinical models.
Our development strategy seeks to initially use our NK-cell product candidate in combination with solid tumor targeting antibodies to induce potent killing of cancer cells. We look forward to providing an update on this program in the coming months.
At the 2015 ASH Annual Meeting, we also plan to present two poster sessions describing our strategy for developing off-the-shelf cancer immunotherapeutic using our disruptive pluripotent cell platform which combines genetic engineering with rapid and efficient generation of immune cells.
We're utilizing our proprietary platform to engineer immunological properties and safety mechanisms at the pluripotent cell stage creating a continual cell source for the generation of off-the-shelf T and NK cancer immunotherapies without requiring patient-sourced cells.
Using our pluripotent cell platform, we have demonstrated the potential to create large quantities of homogeneous cell populations in the hematopoietic lineage using methods that we believe will permit cGMP manufacture and we continue to extensively characterize the property of these cells to demonstrate their safety and efficacy in treating a wide range of solid and liquid tumors.
New scientific data to be presented at ASH, include engineering strategies to efficiently, precisely, and safely integrate multiple genetic modifications in the pluripotent cells, and differentiation strategies using well defined small molecule driven protocols for the derivation of both T- and NK-cells.
Initial in vivo proof of concept for the use of pluripotent cells for off-the-shelf NK-cell cancer immunotherapeutic in solid tumors was recently demonstrated by our collaborator Dr. Dan Kaufman, Professor of medicine and a Member of the Masonic Cancer Center at the University of Minnesota, who publishes findings last week in the journal Stem Cells.
In this manuscript, Dr. Kaufman demonstrated two key findings. One, that a standardized homogenous NK population can be produced efficiently in a large quantities from a human pluripotent cell line.
And two, NK-cells derived from a pluripotent cell line has potent anti-tumor activity in vivo in two different preclinical models of ovarian cancer demonstrating the pluripotent cells have promising potential to be effectively utilize as a source for off-the-shelf NK-cell cancer immunotherapy.
I'd now turn the call back over to Scott for a review of our third quarter financial results..
Thanks Dan. For the third quarter ended September 30, 2015, Fate Therapeutics reported a net loss of $6.9 million or $0.24 per share as compared to a net loss of $6.6 million or $0.32 per share for the same period last year.
Revenue was $1 million for the third quarter of 2015 which was generated from our strategic research collaboration with Juno Therapeutics. Research and development expenses for the third quarter of 2015 were $5 million compared to $4.1 million for the same period last year.
This increase was primarily related to an increase in third-party professional consultant and service provider expenses to support the clinical development of PROHEMA and an increase in personnel expense including stock based compensation expense resulting from additional headcount to support the conduct of our research activities.
General administrative expenses for the third quarter of 2015 were $2.4 million compared to $1.9 million for the same period last year. This increase was primarily driven by increasing personnel expense including stock based compensation expense.
After adjusting for stock based compensation expense of approximately $600,000, total operating expenses for the third quarter of 2015 were $6.8 million.
At the end of the third quarter of 2015, cash and cash equivalents were $72.9 million, debt outstanding under a facility with Silicon Valley Bank was $19.4 million, and common stock outstanding was approximately 28.7 million shares.
Fate Therapeutics is in a strong financial position and we expect that our cash and cash equivalents will be sufficient to fund our operations into mid-2017 without taking into account any future milestone payments, license fees or other sources of cash. With that I'd like to turn the call over to the operator for any questions..
Thank you. [Operator Instructions]. And the first question is from Paul Matteis of Leerink. Your line is open..
Thanks very much. I appreciate it. I have a few. First on the PUMA study, it looks like you've been rolled about 12 patients since May.
So I am curious what is that? Is that in line with your expectations on enrollment? And two, what you guys think is realistic for the size of a pivotal study and would you need to finish PUMA before you guys started with that?.
Thanks Paul. So I can tell you, yes, I think the calculation, I think, you've done is correct in terms of the additional patients that we've enrolled from the May interim analysis.
Generally speaking, I would say that, while are pleased with the results that we're seeing in the clinic with respect to neutrophil engraftment and very much so with respect to the rate of reduction in viral infections, enrollment has been slower than we expected and that is consistent with what we're seeing.
With respect to how many patients we would need for a pivotal study, we are doing those calculations right now. As I mentioned, we are interacting with KOLs and we do plan to have a discussion with the FDA about potential endpoints in a registrational study for our HCT programs.
I think based out of those discussions we will have a firmer idea of the size of the potential pivotal study..
Yeah. Okay great, fair enough.
And in terms of the data generated to-date, I guess you have this upcoming meeting with the FDA, is that meeting before the ASH data or is it after? I guess I'm just trying figure out, how this 17% interim analysis update will be integrated into the package that you submit to them and what you now and how that informs you decision making?.
Yeah. The discussion we're going to have with the FDA is primarily based on the data that we had in May based on that data cut. So we are using the data that is available to us at this time for that discussion. We are going through a process where we're having an additional an additional data cut as I mentioned. We hope to present that data at ASH..
Okay, thanks. And one more if you don't mind. So it sounds like, obviously, while engraftment is important, you're focusing more and more on infection.
So knowing that you had a 64% rate of early engraftment at the previous update which wouldn't have met the primary endpoint, what you see is a successful outcome for the data at ASH? Is engraftment less important now or are you mostly focus on infections? Is that what you want to use in the pivotal study? I know you need some FDA input, but how will you be interpreting the results once you see them in early December?.
Yeah. So I think that's a great question. And yes our 64% rate of early or incidence of early engraftment was slightly below the predesigned endpoint of 70%. Your question is a fair point, and obviously, we are really encouraged by what we're seeing on the infections side.
We think that is a stronger value proposition to both therapeutically as well as pharmacoeconomically.
Some of the comments I made in my prepared remarks, obviously we believe engraftment is an important clinical milestone, an outcome for the patient I think we expect that we should do no harm to engraftment, yet going forward as we think about pivotal studies, registrational strategies as well as ultimately a label for the product, we are focused for instance on reducing infections with our HCT franchise..
Okay, great. And thanks very much, Scott, I appreciate it..
Sure..
Thank you. The next question is from Ren Benjamin of Raymond James. Your line is open..
Hey, good afternoon guys and thanks for taking the questions. So I guess just talking a little bit more about the current PUMA program and how PROTMUNE could fit in all this.
I guess I'm trying to get a sense, is it ever going to be a possibility or do you think about potentially shutting down the umbilical cord program and moving forward with just PROTMUNE once you start getting results given the current rates of transplants being primarily from mobilized peripheral blood?.
Yeah. I think that's a really fair question and we are having conversations right now with KOLs, and we are going to have a conversation with the FDA around what we believe and we think might be the strongest value proposition strategy to proceed in HCT.
We're encouraged by the data absolutely that we're seeing with PROHEMA being able to generate 55% -- 54% reduction in rate of infections, we think is pretty striking so far. We like the value proposition that we provide here essentially a one-time treatment at the time of transplant to prevent infections.
With that said, the preclinical data that we're seeing with PROTMUNE in particular is also very encouraging in acute GvHD as well as infections in the setting of mobilized peripheral blood due are the leading causes of morbidity and non-relapse morbidity and mortality, and so we also do think., we have a very strong value proposition with PROTMUNE.
We will continue to engage KOLs and the FDA and evolve our strategy appropriately based on those discussions as we think about most efficiently creating and moving forward with a product that delivers the most value in allogeneic transplant..
Got it.
And then just in regards to the Phase 1 study that you plan on and starting in 2016, can you comment a little bit about how best you're going to design that study, what are the most important endpoints, obviously, GvHD and infections are, but anything else you're looking for? And then in terms of enrollments like the prior caller had mentioned, the PUMA study has taken longer than expected..
Yes..
And so you know how do you plan on either solving that issue or do you expect that enrollment to pretty much go in line with how you'd seen?.
Yeah. So with respect to the PROTMUNE study, we are very much focused on rates of acute GvHD and rates of infection during the first 100 days following transplant. And as Dan mentioned, we will our IND data package for that at ASH.
I mean we expect to file an IND for that program in the coming months and kickoff a study in 2016 with respect to PROTMUNE when we will look at those prevention strategies.
One of the reasons we are very excited about PROTMUNE in addition to obviously the preclinical data that we're seeing and the value proposition that we think we can deliver both therapeutically and pharmacoeconomically is, we do believe that a mobilized peripheral blood transplant study can enroll much more rapidly.
Mobilized peripheral blood is the source that is used in approximately 65% to 70% of all allogeneic transplant, and so we believe that that is a study both from and first in human experience as well as a registrational study that can enroll more quickly than for instance a cord blood study..
Terrific. Thanks guys and good luck..
Sure..
Thank you. And the next question is from Ted Tenthoff with Piper Jaffray. Your line is open..
Great. Thank you very much for taking the question.
A quick question just with respect to the new immunotherapy assets, how quickly do you think you could actually advance that into the clinic?.
So great question, Ted. And so I think it's something that we are having conversations with right now with respect to our partners at the University of Minnesota.
I think the first product opportunity that has the ability to advance into the clinic is the product candidate that we're advancing with Jeff Miller, the adaptive and K-cell therapeutic that we believe has a clear path to move forward. We're conducting preclinical studies right now with respect to that product candidate.
With respect to the pluripotent cell platform for off-the-shelf cancer immunotherapy, I mean we are really excited about that platform, although I think that is going to take a little bit more time in 2016 to mature on the preclinical side both respect to our ability to generate off-the-shelf T-cells and off-the-shelf NK-cells and the data that we can demonstrate with preclinically..
Great. Fair enough and that's a very exciting early stage program, so I look forward to hearing more about that as it advances..
Okay..
Thank you. [Operator Instructions]. The next question is from Mark Breidenbach of H.C. Wainwright. Your line is open..
Thanks for taking the questions. And Scott congratulations again on the new role, and Christian, we are of course sorry [that you go]. Actually we haven't talked about the recent change in your intellectual property position for the iPSC platform. The patent that was issued last week seems remarkably broad reaching.
And if I'm reading correctly, and it comes to pretty much any methodology that for using pluripotentcy involving the transcription factor opt for and it's diagnostic for the source of tissue or the vectors using the process.
What is the [believe] in terms of other procedures that are uncovered for generating iPSCs?.
I would say, so we've been working on induced pluripotent stem cell technology at Fate Therapeutics since the founding of the Company. Rudolf Jaenisch and Sheng Ding are pioneers in this field, and are two of the first four labs that really were able to demonstrate robust generation of pluripotent cells.
We at the Company Fate Therapeutics being given that Rudolf and Sheng are founders of the Company. We in licensed all their intellectual property exclusively for therapeutic purposes.
We obviously, over the past seven years, have been generating robust intellectual we believe is robust intellectual property at stake to support our pluripotent cell platform, not just around methods of reprogramming, but in terms of methods of maintaining pluripotent cells and then in being able to differentiate those cells into immune cells such as T-cells and NK-cells.
Without overplaying our intellectual property, I absolutely believe our intellectual property is foundational to a pluripotent cell strategy for adoptive immunotherapy, [Opt for] is critical to reprogramming cells, most methods that I am aware of, if not all methods that I am aware of today with respect to generating pluripotent cells involved [indiscernible].
And Rudolf Jaenisch's portfolio, intellectual property product portfolio which we exclusively in license for therapeutic purposes, is really founded on the basis of [Opt for] being critical to the generation of pluripotent cells.
So we think we have a very strong foundational intellectual property position here and one that is very broad for pluripotent cell generation..
Okay, great.
One thing or one way I think about the iPSC platform, essentially it could be used as a blank slate for engineering lymphocytes to really suit the application that they are being tailored for without having to edit out or constitute for too many undesirable characteristics that come along with starting with a differentiated source material.
How close are we to seeing the first target indication that is announced, should we view Dan Coppens' publication as sort of a foreshadowing?.
Yes, I think Dan Coppens' publication that just came out recently is a great example of the potential here that lies ahead with respect to the use of pluripotent cells in the field of cancer immunotherapy.
Obviously, for those have not seen the publication, he just published some interesting data with respect to using pluripotent's cell line to create T-cell and NK-cell therapeutic and then generated proof of concept in two different models of ovarian cancer.
So look I think we are not ready yet to speak about what our first clinical foray is going to be with our pluripotent cell platform whether that be a T-cell or an NK-cell opportunity, whether that be engineered and how we plan to engineer that, all those possibilities are on the table.
And as we progress our platform and talk more publicly about it, obviously we look forward to providing more details around that.
I think at this time, suffice it to say, I think we have a terrific platform here protected by very strong intellectual property and we are generating robust proof of concept in our ability to use pluripotent cell lines to create both T-cells and NK-cells and engineer those cells with targeting mechanisms and safety switches at a pluripotent cell level..
Fantastic. I'm looking forward to seeing the abstracts when they come out Thursday, and it sounds like it's going to be a very busy time at ASH. Congratulations on the process..
Yes. Thank you..
Thank you. The next question is from Ren Benjamin of Raymond James. Your line is open..
Yes, and thanks for taking the follow-up. I just want to ask if the status of both PROVIDE and PROMPT and whether we might be seeing some sort of preliminary results at the end of this year or is it something that would be in a more worthwhile sometimes next year..
Yes. I mean, consistent with the comments I made before with respect to enrollment in PUMA, I would say enrollment and PROMPT and PROVIDE has been slower than we originally expected. So I wouldn't look for an update at ASH with respect to data on those two studies..
Okay.
And just in terms of the Juno collaboration, I know you mentioned that it was off to a very good start, but is there any color you can provide in terms of what stage you are at right now or when a particular endpoint or milestone maybe met where you can reevaluate the collaboration or decide to take a next step?.
Yes. I mean, like I said, I think the collaboration with Juno is off to a very good start. Keep in mind that we've only entered into this collaboration less than six months ago and it is a four-year research collaboration.
We are looking and exploring different mechanisms that we can optimize with respect to the cells themselves and applying our programming approach to really think about ways that we can create the most powerful engineer T-cell immunotherapeutics with them. We have discussed publicly that we are focused on the persistence of T-cells.
Juno has talked about persistence being important for long-term efficacy of Carty. There are other strategies that we are exploring with Juno in order to maximize the therapeutic potential of Carty.
I just think at this point in time given that in a relatively recent history just entered into that collaboration and given it is a four-year research collaboration. I think it's a little too early for us to talk publicly about milestones..
Excellent. Thank you..
Thank you. There are no further questions in queue. I'd like to turn the call back over for closing remarks..
Thank you everyone. I really appreciate spending the time with us today, and we look forward to updating all of you at ASH..
Thank you. Ladies and gentlemen, this concludes today's conference. You may now disconnect. Good day..